Offered twice: Wed March 14 2018 for one hour at UCT 0800 and UTC 1700

According to ICH E6, direct access should be granted to regulatory inspectors to examine, analyze, verify and reproduce any records and reports that are important to evaluation of a clinical trial. What are the considerations and challenges to grant such access in the Sponsor’s systems (e.g. eTMF, EDC, eCRF, ePRO, IVRS…)? Are there different approaches according to the type of systems (on-line/off-line), locations of the inspection (site vs. sponsor vs CRO)? What should sponsor expect from regulatory inspectors (e.g. being trained, hardware/software configurations etc.). Participants are encouraged to share their ideas and experiences!!

Time: This BoF is offered at 2 times in order to accommodate eCF members from around the world: March 14 at UTC 0800 and March 14 at UTC 1700

This BoF Discussion is open to all from eCF Member companies. Please contact suzanne.bishop@eclinicalforum.org to register for this BoF or for information on eCF membership. If you are not a member and would like more information on all the eClinical Forum member benefits, see the membership tab on this site or contact info@eclinicalforum.org and we will be happy to set up a phone meeting to discuss how your organization might fit with eClinical Forum.

Not a member?
Visit the Membership page to learn How To Become a Member (Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)

Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org to suggest topics or get registration information.

Our European meeting of the eClinical Forum will take place in Brussels 15-17 May 2019.

Come along and see why our members are so excited... "ECF are the only meetings I attend each year. It gives me everything I need to stay current and to answer my questions" "People were amazing. Topics were great"